BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.55MM X 10MM FLUTED TWIST DRL

    MDR report key: 3140703 · Received May 31, 2013

    Report

    Report Number
    1045834-2013-02253
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    DEPUY SNYTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUTTER/BURR DEVICE WAS NOT RECEIVED FOR EVALUATION. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(4), REGARDING A CUTTER/BURR DEVICE IN WHICH THE "STERILE PACK WAS DEFORMED". ACCORDING TO THE REPORT, THE LABELING IS WORN ON THE PACKAGING. THE ALLEGED DEFECT WAS OBSERVED UPON RECEIPT OF THE PRODUCT, DURING INSPECTION. THEREFORE, THE DEVICE WAS NOT USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241606 1.55MM X 10MM FLUTED TWIST DRL MOTOR, DRILL, ELECTRIC-CUTTER HBC DEPUY SNYTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1